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Materials Available from FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports

September 22, 2010 4 comments

Did you miss the FDA webinar discussion on the draft reports about the 510(k) process and the use of science in regulatory decisions?  

The webinar was discussed in a August 26, 2010 blog post.  An audiofile of the discussion, along with the background materials,  is available on the CDRH website.  You can listen to the discussion here

FDA is soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348, until October 4, 2010.

Afia Asamoah, Transparency Initiative Coordinator

Upcoming Event: FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports, Tuesday, August 31, 1:00 p.m. ET

August 26, 2010 5 comments

FDA recently published two preliminary reports conducted by the Center for Devices and Radiological Health (CDRH).  The first preliminary report is an assessment of the process used to review certain medical device applications before they are marketed (known as the 510(k) process) and draft recommendations.  The second preliminary report is an assessment of the use of science in CDRH's regulatory decision making and draft recommendations.  This is the first step in determining what, if any, improvements to these processes FDA may implement.

Next week, FDA is hosting a webinar where CDRH officials will discuss the details of both reports.  There will be an opportunity to ask questions.

The live webinar will be held on Tuesday, August 31, at 1:00 p.m. ET.

There are a limited number of spots available for the webinar.  Click here for more information about the webinar, which includes a link to join the webinar on August 31.

FDA is also soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348.

Afia Asamoah, Transparency Initiative Coordinator

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